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The U.S. Supreme Court's Mayo v. Prometheus opinion that claims on a medical diagnostic method cannot be patented did not preclude a finding that claims on isolated DNA as compositions are patent eligible under 35 U.S.C. §101, a split U.S. Court of Appeals for the Federal Circuit ruled Aug. 16 (Association for Molecular Pathology v. United States Patent and Trademark Office, Fed. Cir., No. 2010-1406, 8/16/12).
On remand from the high court, the 2-1 appellate court reaffirmed its earlier conclusion that isolated DNA composition claims were patentable subject matter.
Each of the three panel judges relied on a different standard to assess whether the claims were drawn to chemicals with “markedly different characteristics” than those found in the human body or to patent ineligible products of nature.
They were unanimous once again, though, that related cDNA claims and only one of the related method claims were all patent eligible. They also agreed that one of the plaintiffs had standing, despite his changing jobs between the time the complaint was filed and the time of the court's decision.
The case arose from a 2009 declaratory judgment challenge against patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) for which Myriad is the exclusive licensee (91 PTD, 5/14/09).
The American Civil Liberties Union and the Public Patent Foundation filed the lawsuit on behalf of the Association of Molecular Pathology and other medical associations, individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer.
They argued that claims on isolated DNA, cDNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer were ineligible for patenting under Section 101.
In its first decision, the Federal Circuit agreed that only one of the method claims--Claim 20 of the '282 patent--and all the claims to cDNA are patent eligible, but the court was divided as to claims to isolated DNA. 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (147 PTD, 8/1/11).
A week after its surprising unanimous decision rejecting method claim patent eligibility in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (54 PTD, 3/21/12), however, the Supreme Court granted the ACLU's petition for writ of certiorari in the so-called Myriad case, vacated the Federal Circuit's opinion, and remanded the case for reconsideration (58 PTD, 3/27/12).
The appeals court requested supplemental briefing covering only two points: What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and to method Claim 20 of the '282 patent?
Briefing by the parties and friends of the court provided few surprises (117 PTD, 6/19/12).
Judge Alan D. Lourie, the writer of the original majority opinion, and Judge William C. Bryson, in dissent the first time around, showed little evidence of changed views in oral arguments held July 20 (140 PTD, 7/23/12).
The only question was whether Judge Kimberly A. Moore, who wrote a separate concurring opinion originally, was influenced by Mayo to change her mind.
Again, Lourie wrote the majority's Aug. 16 opinion, Moore wrote a concurring opinion, and Bryson dissented. The three essentially copied the text from their original opinions, interspersing new arguments in light of Mayo where appropriate.
Lourie, again concluding that the isolated DNA claims were patentable subject matter, rejected arguments that the result in Mayo should undermine their patent eligibility.
“While Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court's decisions in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules,” he said, referring to Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 76 USPQ 280 (1948), and Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).
Moore, in a concurring opinion, agreed with the majority's ruling of patent eligibility, but her focus as to the isolated DNA claims was on their utility rather than their composition.
“As an initial matter,” she said, “the Prometheus discussion of laws of nature (process claims) clearly ought to apply equally to manifestations of nature (composition claims).” Nevertheless, she agreed with Lourie that the applicable precedents regarding composition claims remained intact after Prometheus.
“Prometheus did not … overturn Funk Brothers or Chakrabarty; cases clearly more analogous to the one before us,” she said. She applied “the framework” of those two cases “in conjunction with the direction of Prometheus” to the isolated DNA claims at issue here, and she concluded that they are patent eligible.
And as she had done in her original opinion, Moore cited the utility of the claimed isolated DNA as a determining factor under Section 101, and she used that utility to distinguish this case from Mayo v. Prometheus.
“Unlike Prometheus, the claims to short isolated strands of DNA are not directed to the relationship between the mutation and cancer, but rather to a new tool that can be used to determine if that relationship exists,” she said. “The short isolated DNA sequences have markedly different properties which are directly responsible for their new and significant utility.”
As to the patent eligibility of the longer DNA strands, the plaintiffs in their remand arguments to the Federal Circuit seemed hopeful that Moore would reconsider the concern from her original opinion that a ruling against patent eligibility for those claims would disturb the “settled expectations” of the patent community. However, Moore remained steadfast in her concern for those expectations.
“I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved,” she said.
For its part, the Supreme Court in Mayo effectively disregarded predictions that the patent community would be in turmoil when thousands of issued method patent claims were effectively negated by its ruling that the methods at issue there were not patent eligible.
Bryson, in his dissenting opinion, again said that he would have found the isolated DNA claims patent ineligible. He used the Mayo opinion to buttress his views in a couple of ways.
“The majority suggests that I have 'focus[ed] not on the differences between isolated and native DNAs, but on one similarity: their informational content,' ” he said. “In light of Mayo, that approach seems appropriate.”
He found Mayo relevant to the question of whether the isolated DNA claims are effectively drawn to the “informational content”--the nucleotide sequences--rather than to the chemical composition of the DNA. As he had argued previously, he said that the isolated DNA claims should not be patent eligible because “[t]he nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes.”
Again using Mayo for support, Bryson repeated an argument from his original position that, if isolated DNA is found patent eligible, “efforts to sequence almost any gene could infringe [a Myriad claim] even though Myriad's specification has contributed nothing to human understanding of other genes.”
He now pointed to the high court's concern in Mayo about “how much future innovation is foreclosed relative to the contribution of the inventor” and its warning of the “danger” that overly broad patent claims might “foreclose more future invention than the underlying discovery could reasonably justify.”
Lourie, however, discounted Bryson's concerns--essentially that the preemption doctrine was applicable to these claims--and the plaintiff's reliance on policy concerns as overstating the scope of the patent claims and their real-world effects:
[I]t is important to state what this appeal is not about. It is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market encompassed by such a patent--that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter. It is also not whether the claims at issue are novel or nonobvious or too broad. Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. §101 in light of various Supreme Court holdings, particularly including Mayo. The issue is patent eligibility, not patentability.
We would further note, in the context of discussing what this case is not about, that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights. But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us.
The court distinguished the isolated DNA claims from complementary DNA claims in the challenged patents, and they were unanimous in their conclusion that cDNA claims--Claims 2 and 7 of the '282 patent and Claim 7 of the '492 patent--passed muster under Section 101.
The Mayo opinion did not cause the court to make any changes as to that analysis. However, the solicitor general's office submitted a brief and argued before the court July 20 on differences between the isolated DNA and cDNA, and the court added language to the remand opinion accordingly.
“While, as we have held, all of the claimed isolated DNAs are eligible for patent as compositions of matter distinct from natural DNA, the claimed cDNAs are especially distinctive, lacking the non-coding introns present in naturally occurring chromosomal DNA,” the court said. “They are even more the result of human intervention into nature and are hence patent-eligible subject matter.”
The court did not change its views of the method claims at issue in light of Mayo either.
Myriad's method claims challenged by the plaintiffs are of three types:
• Claim 1 of Myriad's '999 patent is representative of “analyzing” claims, as it is directed to detection of BRCA1 gene alteration by analyzing a sequence of the gene from a human sample.
• Claim 1 of the '001 patent is representative of “comparing” claims. It describes a method of screening for the alteration by comparing the human sample to a sample known not to contain the alteration.
• Claim 20 of the '282 patent, covers a “method of screening potential cancer therapeutics” with a step of growing host cells under certain conditions before “determining” whether the rate of growth is indicative of a cancer therapeutic.
The court originally held that the comparing and analyzing steps of the first two types of claims could be accomplished by mere inspection, and so were patent ineligible. In contrast, the court said Claim 20 featured a transformation in manipulating cells and their growth medium and in the physical manipulation of the cells in the determining step.
Mayo clearly could not have made the first two types of claims patent eligible, and the court did not reference Mayo in that context.
The majority--in a portion of the opinion which Bryson joined--acknowledged that the Mayo court held that certain transformative steps are not necessarily sufficient under Section 101. However, the appeals court said, “we once again, even in light of Mayo, arrive at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.”
The appeals court originally held that only one plaintiff--Harry Ostrer, a researcher at New York University School of Medicine who was allegedly interested in sequencing the BRCA1 and BRCA2 genes--met the requirements for declaratory judgment standing.
In its briefing for Federal Circuit rehearing and for Supreme Court review, Myriad argued that even Ostrer should have been denied standing, based on his move to a different lab just before the Federal Circuit's decision. The court denied Myriad's “suggestion of mootness” without comment (115 PTD, 6/15/12).
In the opinion on remand, again one on which all three judges agreed, the court acknowledged Ostrer's move to the new lab, but otherwise did not change its standing analysis as to Ostrer.
The ACLU had argued on remand, though, that if Ostrer had standing, so did organizations to which he belonged. The court disagreed, adding in the remand opinion text.
“The various organizational plaintiffs in this suit in particular were not the target of any enforcement action or offered license agreements by Myriad and had made no preparation to undertake potentially infringing activities,” the court said. “They accordingly suffered no injury and thus lack standing to bring this action.”
“It is extremely disappointing that despite the Supreme Court's ruling, the appeals court has failed to fully re-consider the facts of this case,” the ACLU's Christopher A. Hansen said in a press release. “This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.”
Hansen, staff attorney with the ACLU Speech, Privacy, and Technology Project, represented the plaintiffs in the case. His co-counsel from PUBPAT stated the same policy argument.
“Human genes are not like new genetic tools or drugs, which can be patented because they are manufactured,” said Daniel B. Ravicher, executive director of PUBPAT. “It is absurd to think that a company can own naturally-occurring human genes simply because they removed them from the body.”
Courtenay Brinckerhoff of Foley & Lardner, Washington, D.C., told BNA Aug. 16 that she read Lourie's policy-related comments, quoted above, more to be a reaction to the way this case has played out in the press rather than to the dissent's concerns about preemption.
“Items like the 60 Minutes piece and related news stories have raised multiple policy issues, and I read this passage as a statement by Judge Lourie that these issues should not be (can not be?) addressed by Section 101 of the Patent Act,” she said. She was referring to a segment on the TV show, “Should Firms Be Able to Own Your Genes?”
BNA also identified what appeared to be a conflict between the majority's deferral to Congress to take on the task of “disapproving” certain method patents, compared to the Supreme Court's statement in Mayo describing “the role of Congress in crafting more finely tailored rules where necessary,” in the context of its “disapproval” of the medical diagnostic method claims at issue there.
Brinckerhoff, a member of this journal's board of advisors, said it depended on the starting point.
“If you believe that Section 101 encompasses isolated DNA, then Congress would have to specifically exclude isolated DNA; if you believe that 101 excludes DNA, then Congress would have to specifically include it,” she said.
“That said, to the extent that congressional inaction in the face of an agency's interpretation is a valid tool of statutory construction, Judge Lourie seems to be starting from the correct position.”
Gregory A. Castanias of Jones Day, Washington, D.C., represented Myriad.
By Tony Dutra
Opinion at http://pub.bna.com/ptcj/10140612Aug16.pdf
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